The regenerative surgical treatment of intra-bony peri-implantitis defects with Endobon® (test) versus an established bovine derived bone mineral (control)

Completed

Conditions: infecties rondom tand implantaten
peri-implant bony defects
peri-implant infection

Registration Number: NL-OMON42142

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• During surgical exploration an intra-bony component of at least 3 mm at the deepest point must be present.
• The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.
• The defect must not be wider than 4 mm and the defect angle must be less than 35 degrees from axis of implant.

Exclusion Criteria

• Subjects with diabetes mellitus (HbAlc >= 6.5%)
• Subjects taking corticosteroids or other anti-inflammatory prescription drug
• Subjects taking medications known to induce gingival hyperplasia
• Subjects must not be allergic to penicillin or metronidazole
• Subjects with a history of taking systemic antibiotics in the preceding month
• Subjects must not be pregnant or lactating
• Implants placed in grafted bone or previously augmented with bone substitute or other type of regenerative material
• If stability of the Endobon® granules or control granules cannot be accomplished in the defect
• Failure of obtaining soft tissue closure
• Mobile implants

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is radiographic vertical reduction of the intra-bony<br /><br>peri-implantitis defects for test and control groups at 6 and 12 months after<br /><br>surgery. The difference in defect fill will be measured on the basis of<br /><br>standardized intra-oral periapical radiographs taken with individualized<br /><br>holders at baseline, and 6 and 12 months after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives to evaluate are:<br /><br>1) clinical parameters (pocket probing depth [PPD], clinical attachment level<br /><br>[CAL] from stent margin, bleeding on probing, presence /absence pus)<br /><br>2) patient centered outcomes (subjective satisfaction)<br /><br>3) graft morbidity<br /><br>4) esthetics</p><br>